On March 29, 2007, the Food and Drug Administration announced the recall of Permax (pergolide)—a drug commonly used to manage the symptoms of Restless Leg Syndrome (RLS) and Parkinson’s disease. The recall was prompted by research linking the drug to an increased risk of cardiac valvulopathy, a serious medical condition in which one or more of the heart valves leak.

Since its approval in 1988, Permax has been prescribed to more than half a million Americans. If you are among the many Americans who has taken this drug and suffered a severe side effect, it is in your best interest to consult with an attorney as soon as possible. Contact us today for a free consultation.

Early Warnings, Late Recall
Two studies published in the New England Journal of Medicine in January 2007 demonstrated a significant risk of valvular heart disease in Permax and Dostinex (a similar drug) patients. Even though the risk of heart valve damage was documented as early as 2002, it wasn’t until after this study was published that Eli Lilly—the maker of Permax—agreed to pull the drug from the market.

Mayo Clinic Proceedings
One of the first warnings about the link between Permax and valvular heart disease came in December of 2002 at Mayo Clinic proceedings. Nearly a year later in October 2003, the FDA requested Lilly to revise the drug’s label to include cardiac valvulopathy in the warnings.

University Study
In March 2004, a University of Texas Southwest Medical Center study found a high prevalence of valvular heart disease in patients treated with Permax. The study specifically showed a two- to threefold increased risk of abnormal valves and a 14-fold increased risk of tricuspid regurgitation. Clinicians were advised in April 2004 by an abstract in the Lancet to consider alternative treatments for Parkinson’s patients.

Black Box Warning
The FDA urged Lilly to add a black box warning to Permax’s label to highlight the valvulopathy risk in October 2006. According to the FDA, at least 12 Permax patients have required heart valve transplants.

Contact Experienced Attorneys
The attorneys of Rheingold, Valet, Rheingold, Shkolnik & McCartney have extensive experience helping clients who’ve been injured by dangerous pharmaceuticals. If Permax has harmed you or a loved one, you can learn more about your legal rights and options by contacting us for a free consultation. We look forward to speaking with you.